Zenith Low Profile AAA Endovascular Graft Converter - Graft, vascular, synthetic

Intended purpose

The Zenith Low Profile AAA Endovascular Graft ancillary component, Converter, ZLC, is indicated for the treatment of patients with abdominal aortic or aorto-iliac aneurysms having morphology suitable for endovascular repair, including: • Iliofemoral access vessel size and morphology (minimal thrombus, calcification and/or tortuosity) should be compatible with a 16 French (6.0mm OD) or 17 French (6.5mm OD) vascular introducer sheath; • Non-aneurysmal infrarenal aortic segment (neck) proximal to the aneurysm: o With a length of at least 15mm, o With a diameter measured outer wall to outer wall of no greater than 32mm and no less than 18mm, o With an angle less than 60 degrees relative to the long axis of the aneurysm, and o With an angle less than 45 degrees relative to the axis of the suprarenal aorta. • Iliac artery distal fixation site greater than 10mm in length and 8 to 20 mm in diameter (measured outer wall to outer wall).

Functional description

The Zenith Low Profile AAA Endovascular Graft Converter is part of a modular system consisting of a main body, main body extension and iliac legs and a converter. It is loaded onto a H&L-B One-Shot Introduction System and deployed using a trigger wire system. The Converter can be used to assist in converting a bifurcated graft into an aortouni-iliac graft if necessary. The main body graft wire guide is used to introduce the converter into the main body.